General Summary:
- The Process Chemistry Principal Scientist is a technically self-reliant expert who identifies and solves complex problems across critical and diverse projects, advising project teams regularly.
Key Duties and Responsibilities:
- Designs and performs sophisticated, technically challenging experiments independently, ensuring compliance with applicable regulations and SOPs.
- Generates effective hypotheses to pursue project goals and sets new experimental direction.
- Identifies broad implications of results and their impact on the overall study.
- Develops novel and creative solutions to overcome project obstacles.
- Makes substantive conceptual contributions to project activities and scientific strategies.
- Provides authoritative technical recommendations within the company and plays a key formal or informal project role.
- Manages CRO interactions and external collaboration.
Knowledge and Skills:
- Demonstrated ability to work successfully in cross-functional teams.
- Experience drafting, reviewing, and submitting required documentation for development and preparation of drug substances under a cGMP environment.
- In-depth conceptual knowledge of SOPs and GMPs; ensures compliance with applicable regulations and SOPs.
- Ability to draft CMC sections of INDs or CTAs (plus).
- Experience writing and transferring developed technology to outside CROs and working with suppliers to resolve chemical issues for compound delivery.
- Excellent verbal and written communication skills; prepares presentations and reports.
Education and Experience:
- Bachelor’s degree in a relevant field.
- Bachelor’s degree and 10+ years of experience, or Master’s degree and 7+ years of experience, or PhD and 4–7 years of experience (or equivalent combination).
Compensation and Benefits (as stated):
- Pay range: $138,000 - $207,000.
- Eligible for annual bonus and annual equity awards.
- On-Site role: five days per week on-site with ad hoc flexibility.
Application Instructions:
- Not specified in the provided text.